Corneal Endothelial DystrophyPhase 2OPTICNCT04812067
A Safety and Efficacy Trial of TTHX1114 in People With CED
A Phase 2 study testing TTHX1114 in people with Corneal Endothelial Dystrophy, run by Trefoil Therapeutics, Inc. at 2 sites in United States.
Trial summary
Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Endothelial Dystrophy
- What is being tested?
- TTHX1114
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2021to 31 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older
- Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
- Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
- Fellow Eye with 20/100 BCVA or better
- No concurrent ocular or medical condition that would impair the assessment of safety and efficacy
Who cannot join
- Prior exposure to TTHX1114
- Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
- Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
- History of:
- Ocular cancer (including melanoma)
- Herpetic keratitis
Show all 11Show fewer
- Documented and repeated elevated IOP in either eye
- Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
- Uveitis
- Use of any concomitant medications that may interfere with the assessment of safety and efficacy
- Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Trefoil Study Site
Atlanta, Georgia, 30342
Trefoil Study Site
Washington, Missouri, 30090
About this study
Official title: A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection
Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114
- Conditions
- Corneal Endothelial Dystrophy
- Being tested
- TTHX1114
- Medical subject headings
- Corneal Dystrophy, Posterior Polymorphous, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTHX1114Drug
engineered FGF-1
| Study group | Role | What they receive |
|---|---|---|
| TTHX1114 weekly x 5 | Experimental | TTHX1114 via IC injection weekly x 5 Receives: Drug: TTHX1114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specular Microscopy
Corneal Endothelial Cell Density
Measured: Day 28
Secondary outcomes (1)
Pachymetry
Central Corneal Thickness
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start30 Nov 2021
- Primary completion29 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trefoil Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Tremblay, Study director, Trefoil Therapeutics.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812067
- Sponsor's protocol ID
- TTHX-901
- Acronym
- OPTIC
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection
- ClinicalTrials.gov ID
- NCT04812067
- Acronym / sponsor ID
- OPTIC / TTHX-901
- Conditions
- Corneal Endothelial Dystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Trefoil Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTHX1114 weekly x 5 | Experimental | Drug: TTHX1114TTHX1114 via IC injection weekly x 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 years of age or older
- Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
- Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
- Fellow Eye with 20/100 BCVA or better
- No concurrent ocular or medical condition that would impair the assessment of safety and efficacy
Key exclusion criteria (11 listed)
- Prior exposure to TTHX1114
- Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
- Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
- History of:
- Use of any concomitant medications that may interfere with the assessment of safety and efficacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTHX1114engineered FGF-1 | Drug | TTHX1114 weekly x 5 |
Primary outcome
Specular Microscopy
Time frame: Day 28
Corneal Endothelial Cell Density
1 secondary outcome
Pachymetry
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Tremblay study director
Trefoil Therapeutics.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTHX1114 in people with Corneal Endothelial Dystrophy, run by Trefoil Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specular Microscopy (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.